Study of the Trifunctional Antibody FBTA05 and Donor Lymp... | NCT01138579

Studies
Study of the Trifunctional Antibody FBTA05 and Donor Lymphocyte Infusion in B-cell Lymphoma After Allogeneic Stem Cell Transplantation

NCT01138579

Sponsor

Technical University of Munich

Status

Withdrawn

Last Update Posted

Dec 7, 2022Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Leukemia
Stem Cell Transplantation

Interventions

FBTA05

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment delayed, trial medication no loner available

Expanded Access Info

Start Date

Aug 2010Estimated

Primary Completion Date

May 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Jun 4, 2010

First Submission Date that Met QC Criteria

Jun 4, 2010

First Posted Date

Jun 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2022

Last Update Posted Date

Dec 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
1	Experimental		Drug: FBTA05

Name	Type	Description	Arm Group Labels	Other Names
FBTA05	Drug		1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient´s written informed consent
≥ 18 years of age; male and female
Confirmed CLL, low grade NHL or high grade NHL on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies
CD20 positivity (if not already confirmed)
Adequate haematological, liver and kidney functions
Platelet count ≥25,000mm³ (=25 x 10^9/l)
Patients with active disease (relapsed/refractory) that survived at least 60 days after allogeneic transplantation
Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Appendix IV)
Negative pregnancy test (no more than 2 days before enrolment) and adequate contraception during the study in women of child bearing potential (pre- menopausal, <2 years post-menopausal or not surgically sterile)

Exclusion Criteria:

Any anti-CD20 and / or any other anti-T cell directed antibody treatments < 3 months before application of FBTA05
Positivity for human anti-mouse antibodies (HAMAs)
History of GvHD ° III or IV, or GvHD requiring steroid therapy with more than 10 mg/day
Known or suspected hypersensitivity to recombinant, murine or rat proteins
AST/SGOT greater than 10 x ULN (grade 3, CTCAE)
Bilirubin greater than 5 x ULN (grade 3, CTCAE)
Creatinine greater than 3.5 mg/dl (grade 3, CTCAE)
Acute or uncontrolled chronic infections, viral infections at risk of reactivation (e.g.HCV, HBV, HIV)
Unable or unwilling to comply fully with the protocol
Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
3. Medizinische Klinik, Klinikum rechts der Isar der TU München		Munich	Bavaria		Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34515338	Derived	Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
23815981

Measure	Description	Time Frame
Phase I: Determination of the maximum tolerated dose (MTD)
Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI

ID	Term
D007938	Leukemia
D008228	Lymphoma, Non-Hodgkin

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases